FDA Clears ClearMate Device to Treat Carbon Monoxide Poisoning

The Food and Drug Administration (FDA) has granted marketing clearance for ClearMate (Thornhill Research), a device intended for use in an emergency room (ER) setting to help treat patients with carbon monoxide poisoning.

Currently, the standard treatment for carbon monoxide poisoning is delivering 100% oxygen to the patient through a mask, and in severe cases, through the use of a hyperbaric chamber. However, only 60 medical centers in the US have hyperbaric units. “[These] medical facilities are seldom in rural areas, so treatment in those areas could be delayed considerably due to transport time,” said Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health.

ClearMate increases carbon monoxide removal from the body by increasing the patient’s rate of respiration. The device consists of a gas mixer, valves, meters, breathing circuits, an oxygen reservoir, a mask, and hoses. It works by delivering 100% oxygen to the patient, as well as a mixture of oxygen and carbon dioxide that increases respiration. The increased breathing leads to increased carbon monoxide elimination, thus allowing a normal amount of oxygen to attach to hemoglobin.

The FDA approval was supported by data from clinical studies which compared treatment with 100% oxygen alone vs use of the ClearMate device. Results showed that the device was more effective than 100% oxygen alone in eliminating carbon monoxide, however, it was not faster than hyperbaric oxygen therapy. With regard to safety, no device-related complications were reported among the study patients.